check_circleStudy Completed
Breast Cancer, Diagnostic Imaging
Bayer Identifier:
91743
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Efficacy and safety of gadobutrol 1.0 molar (Gadovist) for breast MRI
Trial purpose
The purpose of this study is to look at the efficacy (how does it work) and safety of gadobutrol when used for obtaining MR images of both breasts.Women with a recent diagnosis of breast cancer by mammogram (X-ray examination of the breasts) may benefit from MRI of the breasts as MRI may detect additional breast cancers.
Key Participants Requirements
Sex
BothAge
18 YearsTrial summary
Enrollment Goal
446Trial Dates
February 2010 - January 2012Phase
Phase 3Could I Receive a placebo
NoProducts
Gadavist/Gadovist (Gadobutrol, BAY86-4875)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Lübeck, 23538, Germany | |
Completed | Magdeburg, 39120, Germany | |
Withdrawn | Hannover, 30625, Germany | |
Completed | Newport Beach, 92658-6100, United States | |
Terminated | Hospital Italiano Buenos Aires | Buenos Aires, C1181ACH, Argentina |
Terminated | Investigaciones Médicas | Buenos Aires, C1082A, Argentina |
Completed | Seoul, 150-713, Korea, Republic Of | |
Completed | Seoul, 138-736, Korea, Republic Of | |
Completed | Tübingen, 72076, Germany | |
Completed | Essen, 45257, Germany | |
Completed | Essen, 45147, Germany | |
Completed | Marburg, 35033, Germany | |
Completed | Potsdam, 14467, Germany | |
Completed | Dortmund, 44263, Germany | |
Completed | Bielefeld, Germany | |
Withdrawn | Boston, 02118, United States | |
Completed | Los Angeles, 90033, United States | |
Completed | La Jolla, 92093, United States | |
Completed | San Antonio, 78229, United States | |
Completed | Springfield II, 62781, United States | |
Terminated | Centro de Diagnóstico Dr. Enrique Rossi | Buenos Aires, C1425BEE, Argentina |
Completed | Seoul, 135-710, Korea, Republic Of | |
Completed | Milano, 20097, Italy | |
Completed | Napoli, 80131, Italy | |
Withdrawn | Udine, 33100, Italy | |
Completed | Milano, 20141, Italy | |
Completed | Milano, 20132, Italy | |
Completed | Bogotá, Colombia | |
Completed | MEDELLIN, Colombia | |
Withdrawn | Barranquilla, Colombia | |
Terminated | Hospital Israelita Albert Einstein | São Paulo, 05651-901, Brazil |
Terminated | Clinica de Diagnostico por Imagem | Rio de Janeiro, 22649, Brazil |
Terminated | Hospital Clínicas FMUSP | Sao Paulo, Brazil |
Completed | Gyeonggi-do, 425-707, Korea, Republic Of | |
Withdrawn | Chur, 7000, Switzerland | |
Withdrawn | Bern, 3010, Switzerland | |
Completed | Baden, 5404, Switzerland | |
Completed | Tampere, 33521, Finland | |
Completed | Washington, 20007-2197, United States | |
Completed | Docrates | Helsinki, 00180, Finland |
Primary Outcome
- Sensitivity for detection of full extent of malignant breast disease using CMRM vs UMRM per readerFor a single participant the sensitivity was defined as the proportion of malignant breast regions that were recognized by the reader using the respective imaging modality as malignant. Subsequently the point estimates were calculated based on the mean of the sensitivities across all participants. For ease of expression, the following abbreviations will be used: Magnetic Resonance Mammography (MRM), Unenhanced MRM (UMRM), combined unenhanced and contrast (gadobutrol)-enhanced MRM (CMRM), X-ray mammography (XRM)date_rangeTime Frame:Immediately before injection and after injectionenhanced_encryptionNoSafety Issue:
- Difference for sensitivity for detection of full extent of malignant breast disease using CMRM vs UMRM per readerFor a single participant the sensitivity was defined as the proportion of malignant breast regions that were recognized by the reader using the respective imaging modality as malignant. Subsequently the point estimates were calculated based on the mean of the sensitivities across all participants.date_rangeTime Frame:Immediately before injection and after injectionenhanced_encryptionNoSafety Issue:
- Breast level specificity of CMRM for non-malignant breasts by readerA non-malignant breast was defined as false positive (FP), when the reader assessed at least one breast region as malignant. When all breast regions were assessed as non-malignant, the breast was defined as true negative (TN). Breast level specificity was first defined in participant as number of TN-breasts in participant divided by number of non-malignant breasts in participant. Subsequently the point estimates were calculated based on the mean of the specificities across all participants who contributed with at least one non-malignant breast.date_rangeTime Frame:Immediately before injection and after injectionenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Breast level specificity of CMRM based on malignant breastsA malignant breast was defined as false positive (FP), when the reader using the respective imaging modality assessed more breast regions as malignant as were present according to SoT. Otherwise the breast was assessed as true negative (TN). Specificity was then defined as TN/(TN+FP).date_rangeTime Frame:Immediately before injection and after injectionenhanced_encryptionNoSafety Issue:
- Percentage difference of participants whose index cancers were detected using CMRM vs UMRM, CMRM vs XRM, and CMRM vs CMRM+XRMIndex cancer is defined as the cancer confirmed by histology prior to inclusion which made the participants eligible for the study.date_rangeTime Frame:Immediately before injection and after injectionenhanced_encryptionNoSafety Issue:
- Percentage difference of participants whose additional cancers were detected using CMRM vs UMRM, CMRM vs XRM, and CMRM vs CMRM+XRMAdditional cancer was defined as cancer which was present according to SoT, but which was not defined as index cancer, i.e. was not known when the participant was enrolled into the study.date_rangeTime Frame:Immediately before injection and after injectionenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
DiagnosticAllocation
Non-randomizedBlinding
Open LabelAssignment
Single Group AssignmentTrial Arms
1Additional Information
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